CTRI/2020/03/024100已完成4 期
Single blind, randomized study comparing clinical equivalence of Trusilk�® (Healthium) and Mersilk�® (Johnson & Johnson) silk suture, for primary closure of mucosa in subjects undergoing planned surgical removal of mesioangular impacted mandibular third molar
Healthium Medtech PvtLtd formerly Sutures India Pvt Ltd0 个研究点目标入组 132 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 132
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Subjects, both male and female, aged 20-40 years
- •2. Subjects having mesioangular impacted mandibular 3rd molar
- •3. Subjects requiring mucosal suturing
- •4. Subjects who have given informed consent
- •5. Subjects classified under ASA I and II
排除标准
- •1. Subjects having infected molar teeth or complicated impacted 3rd molar
- •2. Pregnant or lactating women
- •3. Subjects with history of allergy to silk or similar products
- •4. Subjects on drugs like aspirin, blood thinners and anticoagulant therapy
- •5. Subjects receiving any type of local and systemic drugs which can produce inflammation in gingival tissue
- •6. Subjects with history of systemic diseases such as diabetes mellitus, tuberculosis, bleeding disorders, osteoporosis, unstable or life-threatening conditions, those undergoing radiation therapies.
- •7. Subjects those who had the habit of drug abuse
- •8. Subjects already participating in another trial
- •9. Subjects who received an experimental drug or used an experimental medical device within 30 days prior to the planned start of procedure
- •10. Subjects unlikely to comply with surgical procedure or complete the scheduled follow up visit, in the opinion of investigator
- •11. Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center
- •12. Other indication or the reason for exclusion, in the opinion of investigator
研究者
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